CLINICAL TRIALS PROFILE FOR ASTAGRAF XL

505(b)(2) Clinical Trials for ASTAGRAF XL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT07033858 ↗	Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation	RECRUITING	Shahid Beheshti University of Medical Sciences	NA	2025-03-01	Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf/Astagraf XL, Astellas company).

All Clinical Trials for ASTAGRAF XL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01962922 ↗	Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.	Completed	Veloxis Pharmaceuticals	Phase 3	2013-11-01	Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
NCT02221583 ↗	Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy	Completed	Astellas Pharma Inc	Phase 4	2014-05-01	The purpose of this study is to evaluate how quickly and to what extent different immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system is the body's defense against diseases. It also attacks "foreign" tissues such as a transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL), Prograf, and mycophenolate mofetil may be given to suppress the immune system following kidney transplantation and prevent rejection of a transplanted kidney. This study is being performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different doses of immunosuppressant medications.
NCT02221583 ↗	Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy	Completed	University of Cincinnati	Phase 4	2014-05-01	The purpose of this study is to evaluate how quickly and to what extent different immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system is the body's defense against diseases. It also attacks "foreign" tissues such as a transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL), Prograf, and mycophenolate mofetil may be given to suppress the immune system following kidney transplantation and prevent rejection of a transplanted kidney. This study is being performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different doses of immunosuppressant medications.
NCT02339246 ↗	Pharmacokinetic Comparison Of All FK-506 Formulations	Completed	Veloxis Pharmaceuticals	Phase 3	2015-01-01	The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.
NCT02444143 ↗	A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients	Completed	Astellas Pharma US, Inc.	Phase 4	2015-05-01	Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).

Clinical Trial Conditions for ASTAGRAF XL

Condition Name

Condition Name for ASTAGRAF XL
Intervention	Trials
End Stage Renal Disease	2
Kidney Transplantation	2
Renal Failure	2
Heart Failure	1

Condition MeSH

Condition MeSH for ASTAGRAF XL
Intervention	Trials
Renal Insufficiency	2
Kidney Failure, Chronic	2
Heart Failure	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for ASTAGRAF XL

Trials by Country

Trials by Country for ASTAGRAF XL
Location	Trials
United States	30
Iran	1

Trials by US State

Trials by US State for ASTAGRAF XL
Location	Trials
Illinois	3
South Carolina	2
Colorado	2
California	2
New Jersey	2

Clinical Trial Progress for ASTAGRAF XL

Clinical Trial Phase

Clinical Trial Phase for ASTAGRAF XL
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
NA	1

Clinical Trial Status

Clinical Trial Status for ASTAGRAF XL
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for ASTAGRAF XL

Sponsor Name

Sponsor Name for ASTAGRAF XL
Sponsor	Trials
Astellas Pharma Inc	3
Veloxis Pharmaceuticals	2
University of Cincinnati	1

Sponsor Type

Sponsor Type for ASTAGRAF XL
Sponsor	Trials
Industry	7
Other	7

Last updated: April 28, 2026

Astagraf XL Clinical Trials Update, Market Analysis, and Projections

What is Astagraf XL and what are the current clinical program signals?

Astagraf XL (tacrolimus extended-release) is a once-daily formulation used for prevention of organ rejection in transplant patients. The clinical evidence base for tacrolimus is mature, and the extended-release product is positioned as a dosing convenience and adherence lever rather than a new mechanism entrant.

Observed clinical-trial signal in the public domain (high level)

• The Astagraf XL clinical landscape is dominated by:
  • Pivotal/registration-era studies supporting efficacy and safety versus comparator tacrolimus regimens.
  • Ongoing, smaller-scale mechanistic or real-world adherence, tolerability, and pharmacokinetic refinements typical of mature transplant brands.
• The absence of widely reported, late-stage (Phase 3) new-to-market programs tied to Astagraf XL specifically indicates the product is in an established utilization and life-cycle management phase rather than a “build a new label” phase.

Practical implication for R&D and investment

• Near-term differentiation is more likely to come from:
  • Patient selection and switch programs (conversion from twice-daily tacrolimus or other CNI regimens).
  • Formulation and adherence optimization.
  • Health economics and reimbursement positioning rather than new clinical endpoints.

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What does the market look like for Astagraf XL (tacrolimus extended-release)?

Market structure

• Tacrolimus is a backbone immunosuppressant in solid organ transplant care (kidney first-line, plus other indications depending on label and country).
• Extended-release tacrolimus competes against:
  • Immediate-release tacrolimus brands and generics
  • Other once-daily tacrolimus options (where available by geography)
• Competitive pressure typically comes from:
  • Patent and exclusivity expiry windows
  • Generic penetration of immediate-release tacrolimus
  • Payer preference for lowest-cost effective tacrolimus strategies

Demand drivers

• Transplant incidence (kidney transplant volumes, maintenance therapy duration)
• Adherence and dosing convenience preferences for once-daily regimens
• Payer policies emphasizing cost offsets versus clinical outcomes

Commercial reality for a once-daily CNI

• Astagraf XL’s value proposition is predominantly operational:
  • Once-daily dosing vs multiple daily dosing approaches
  • Potential adherence improvements in long-term maintenance therapy
• In heavily generics-exposed classes, brand share depends on:
  • Formulary placement
  • Contracting discounts
  • Switch protocols and clinician familiarity

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How should a projection be modeled (base case, bull case, bear case)?

Because transplant maintenance is long duration, projections are best framed as a share + price + volume model, where tacrolimus volumes are relatively stable but brand economics shift with:

• Generic penetration depth and speed
• Payer contracting (net price erosion)
• Use of extended-release formulations relative to immediate-release

Projection framework (3-scenario model inputs)

Variable	Bear case	Base case	Bull case
Net price trend	Steeper erosion from formulary pressure	Moderate erosion	Slower erosion from stronger contracting
Share retention of ER tacrolimus	Declines faster as payers prefer lower cost IR/generic	Stabilizes with managed conversion	Improves with adherence and switch programs
Total transplant maintenance demand	Flat to slight growth	Moderate growth aligned with transplant volumes	Higher growth via expanded uptake and favorable coverage

What the model will likely show for Astagraf XL

• Base case: gradual net price decline offset partially by stable underlying transplant maintenance demand and sustained ER positioning.
• Bear case: acceleration in price erosion and share loss as payer formularies shift toward least-cost options.
• Bull case: ER share holds with better-than-expected contracting and conversion performance, slowing net revenue decline.

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What are the key competitive and lifecycle risks?

Risk factor	Why it matters	Expected commercial effect
Generic competition in tacrolimus class	IR tacrolimus generics compress benchmark pricing	Downward net price pressure across branded ER options
Formulary design and step therapy	Payers can steer to lowest net cost	Share leakage from ER maintenance
Conversion friction	Switching stable patients can be clinically and operationally harder	Limits rapid share gains
Safety/tolerability variability across patients	High-touch monitoring requirement in practice	Can affect persistence and payer willingness

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What is the most actionable outlook for Astagraf XL commercialization?

Actionable commercial levers

• Payer contracting strategy: tie ER tacrolimus positioning to measurable outcomes payers accept (persistence, adherence, resource utilization).
• Conversion playbooks: target conversion cohorts where clinicians expect operational fit (newly transplanted or patients with adherence issues).
• Therapeutic monitoring support: tighten real-world therapeutic drug monitoring processes to maintain physician confidence in ER tacrolimus stability.

Investment/R&D lens

• The ROI case for any life-cycle investment in Astagraf XL should be anchored to:
  • Reduced total cost of care via adherence/persistence outcomes
  • Maintained share in ER sub-segment versus erosion from tacrolimus generics

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Key Takeaways

• Astagraf XL is a mature, once-daily tacrolimus extended-release product whose clinical program activity is largely life-cycle and real-world oriented rather than dominated by new late-stage breakthroughs.
• Market growth is driven by long-duration transplant maintenance demand, but branded economics face continuous pressure from generic tacrolimus pricing and payer formulary management.
• Projections should be modeled with net price erosion + ER share retention as the dominant levers; total transplant volume growth is typically secondary to payer contracting and competitive dynamics.
• The highest-leverage commercial strategy is payer contracting plus conversion execution into ER tacrolimus cohorts with consistent persistence.

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FAQs

1) Is Astagraf XL differentiated by mechanism?

No. It is tacrolimus extended-release, so differentiation in the market is primarily dosing convenience, adherence, and operational fit rather than a new mechanism.

2) What typically drives revenue changes for ER tacrolimus brands?

Net price and formulary position. Brand demand usually shifts toward lowest net-cost tacrolimus strategies when payer pressure increases.

3) Do clinical trials still matter for a mature transplant brand like Astagraf XL?

Yes, but the role is often label reinforcement, real-world utilization evidence, adherence or tolerability characterization, and conversion support rather than new Phase 3 registration studies.

4) How do generics typically impact Astagraf XL projections?

They pressure reference pricing across tacrolimus regimens and can increase payer steering toward least-cost immediate-release tacrolimus options.

5) What is the most realistic growth pathway for Astagraf XL?

Share stabilization or incremental gain within the ER tacrolimus segment via payer contracting and patient conversion programs, rather than relying on major new clinical expansions.

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References

[1] U.S. Food and Drug Administration. Astagraf XL prescribing information. FDA.
[2] European Medicines Agency. Astagraf XL (tacrolimus extended-release) assessment history and EPAR documentation. EMA.
[3] ClinicalTrials.gov. Search results for “Astagraf XL” and “tacrolimus extended release”. National Library of Medicine.
[4] Published clinical literature on tacrolimus extended-release in solid organ transplant maintenance.